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cobas EBV, cobas EBV/BKV Control Kit, cobas Buffer Negative Control Kit

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
DEN200015
510(k) Type
Direct
Applicant
Roche Molecular Systems, Inc.
Country
United States
FDA Decision
Deleted
Decision Date
7/30/2020
Days to Decision
150 days

cobas EBV, cobas EBV/BKV Control Kit, cobas Buffer Negative Control Kit

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
DEN200015
510(k) Type
Direct
Applicant
Roche Molecular Systems, Inc.
Country
United States
FDA Decision
Deleted
Decision Date
7/30/2020
Days to Decision
150 days